Senior Technical Specialist
United States, Walkersville (Maryland)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
The Technical Services Specialist, Quality Control leads the introduction of new methods and processes into the Quality Control (QC) department via the technology transfer process, represents the department on project/product teams, and provides technical support during investigations.
- Provides QC representation to project/product team meetings. Responsible for relaying pertinent information such as production schedules and information requests to applicable QC labs. Provides routine feedback regarding technology transfer and testing status. Supports stability program by gathering information needed to initiate protocols and tracks status of timepoint summaries. Relays status updates in a timely and accurate manner.
- Supports implementation of site-wide/departmental projects and initiatives.
- Develops, monitors, and reports metrics to assess the efficiency and success of technology transfer activities and tech services group projects.
- Assists supervisor with ensuring adequate coverage of client meetings/projects. May assume leadership responsibilities in supervisor’s absence.
- Participates in the initial assessment of new products and processes. Provides input to program/product management regarding QC capabilities and requirements for method qualification/validation. Reviews applicable regulatory guidance and internal policy documents to ensure compliance.
- Provides technical review of Statements of Work (SOWs) to support contract manufacturing activities.
- Writes, reviews, and/or approves SOPs, sampling plans, and QACS for new parts.
- Assists with responses to audits, deviations, out of specification (OOS) investigations, customer complaints, and corrective/preventative actions (CAPA).
- Leads and mentors others with technical investigations.
- Works in cooperation with BioAssay Services and Manufacturing Science and Technology teams to design assay transfer, qualification, and validation protocols. May participate in the execution of such protocols and may perform routine or specialized testing as needed to support lab(s).
- Assists with QC procurement, setup, and validation activities for new equipment required to support new methodology.
- Bachelor’s degree in a scientific discipline.
- Experience with method validation and technology transfer required.
- Knowledge of compendial microbiological and biological cell based assays such as proliferation, flow cytometry, ELISA, cytochemical and immunoflourescence microscopy preferred.
- Proficient in the use of spreadsheets, databases, and word processing software.
- Performs statistical analysis of data.
- Knowledge of SAP and TrackWise systems a plus.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.